LISA (Lactoferrin InStead of Antibiotics) feasibility study v1
Research type
Research Study
Full title
Is the naturally occurring prebiotic Lactoferrin an acceptable alternative to antibiotic tablets for women with bacterial vaginosis or thrush? The LISA (Lactoferrin InStead of Antibiotics) randomised feasibility study.
IRAS ID
307899
Contact name
Pippa Oakeshott
Contact email
Sponsor organisation
St George's University of London
Duration of Study in the UK
1 years, 11 months, 2 days
Research summary
Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush/candida infection at least once. Symptoms can include abnormal vaginal discharge, soreness, itching and an unpleasant smell. Recurrent infections may need repeated treatments which can encourage the growth of resistant superbugs.
Lactoferrin is a harmless prebiotic protein derived from cow’s milk. Research suggests Lactoferrin might be an effective treatment for BV/thrush.
Aim
To see if it is feasible to conduct a future trial to prove whether lactoferrin vaginal pessaries are an acceptable, effective and cost-effective alternative to antibiotic tablets for women with BV or thrush.
What we will do
We will recruit a total of 57 women with BV and 57 with thrush from two sexual health clinics and a general practice. We will ask women to provide self-taken vaginal samples with a cotton bud, and to complete a confidential sexual-health questionnaire. Then the women will be divided into two groups. One group will be given lactoferrin vaginal pessaries to use every night for 3-weeks. The other group will be given antibiotic tablets. All women will be asked to provide repeat vaginal samples at home and text us about any symptoms so we can see if the treatment works and if the infection comes back. After 12-weeks all women will be invited back for a final check-up and given £30.
We will measure:
• Acceptability and use of vaginal lactoferrin - from questionnaires, and interviews with 15-20 women
• Recruitment and follow-up rates
• Cost of lactoferrin treatment
• The percentage of women in each group who report their symptoms have resolved after 2-weeks
• How quickly infections clear or recur - from analysis of samples
Patient benefit
If this study leads to a trial showing vaginal lactoferrin is an effective alternative to antibiotics, this could help relieve symptoms, prevent antimicrobial resistance and save NHS costs.REC name
London - South East Research Ethics Committee
REC reference
22/LO/0078
Date of REC Opinion
18 Feb 2022
REC opinion
Unfavourable Opinion